Materials availability is a factor in vaccine production.

Supply Chain Hurdles for Vaccine Production

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Boosting Drug Development

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The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

FDA Weighs in on Remote Inspections

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

FDA Accepts IND for Airway Therapeutics’ Treatment for Severe COVID-19 Patients

Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Eli Lilly Modifies COVID-19 Purchase Agreement with the US Government

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Plasma-Based COVID-19 Treatment Alliance Ends its Project as Trial Fails to Meet Endpoints

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

Catalent Expands COVID-19 Vaccine Fill/Finish Collaboration with Moderna

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

FDA Makes Revisions to Moderna’s COVID-19 Vaccine EUA to Increase Available Doses

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

J&J to Take Over Its Product Manufacturing at Emergent Facility

The availability of materials is a critical factor when it comes to vaccine capacity.

Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production

Smart, accurate, science-based messaging is needed to advance bio/pharma science.

Avoiding Unforced Errors in the Bio/Pharma Industry

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.

Ingredient Mix Up Ruins 15 Million Doses of J&J Vaccine

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses. 

Pfizer-BioNTech COVID-19 Vaccine Shows Positive Results in Clinical Trial for Adolescents

GSK will provide filling capacity at its Barnard Castle facility in England.

GSK to Support Manufacture of Novavax' COVID-19 Vaccine Candidate

Celonic will manufacture CvnCoV at its facility in Germany.

Celonic Group to Manufacture CureVac’s mRNA COVID Vaccine Candidate

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

Celltrion Receives a Positive Opinion from CHMP for Regdanvimab

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany. 

EMA Approves BioNTech’s COVID-19 Vaccine Manufacturing Site

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

EMA Adopts Recommendations to Increase COVID-19 Vaccine Capacity

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021. 

J&J to Supply the African Union with 200 Million Doses of its COVID-19 Vaccine

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

AstraZeneca Confirms Vaccine Efficacy with Phase III Primary Analysis

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

COVID-19 Update

Supply Chain Hurdles for Vaccine Production

Boosting Drug Development

Innovating to Fight the Pandemic